Polyscrew Pedicle Screw System— 510(k) K150647

Name: FDA 510(k) clearance K150647
Creator: U.S. Food and Drug Administration
Published: 2015-04-08

Substantially Equivalent

New Era Orthopedics, LLC

FDA 510(k) clearance K150647 for Polyscrew Pedicle Screw System, Substantially Equivalent on 2015-04-08. Applicant: New Era Orthopedics, LLC. Device class: 2.

Clearance details

Applicant: New Era Orthopedics, LLC
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2015-03-12
Decision date: 2015-04-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Hummelstown, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K150647

K-number listed on FDA's recall record

Z-2604-2018 — Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07Class II·Terminated·New Era Orthopaedics, LLc·20170213

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150647.

Data sourced from openFDA. This site is unofficial and independent of the FDA.